Cleary, James M. http://orcid.org/0000-0001-7213-3951
Calvo, Emiliano
Moreno, Victor
Juric, Dejan
Shapiro, Geoffrey I.
Vanderwal, Carol Ann
Hu, Beibei
Gifford, Maryella
Barch, David
Roberts-Rapp, Lisa
Ansell, Peter J.
Xiong, Hao
Ocampo, Christopher
Tolcher, Anthony W.
Funding for this research was provided by:
AbbVie (n/a)
Article History
Received: 9 January 2020
Accepted: 30 January 2020
First Online: 18 March 2020
Compliance with ethical standards
:
: JM Cleary: Research funding from Merck and Tesaro, consultant to Bristol-Myers Squibb, travel funding from Bristol-Myers Squibb, Agios, and Roche.E Calvo: Consulting/advisory role with Novartis, GSK, Astellas, Roche/Genentech, Eli Lilly, Nanobiotix, Pfizer; speakers’ bureau for Novartis; research funding from Boehringer Ingelheim, Roche/Genentech, BMS, Novartis, PsiOxus, Janssen, Eisai, AbbVie, OncoMed, PharmaMar, Puma, Spectrum, Sanofi, Eli Lilly, Pfizer, Merck, Nektar, Millennium; travel/accommodations/expenses reimbursed by Eli Lilly, PsiOxus, Novartis.V Moreno: Consulting fees from Merck, BMS; travel support from Regeneron/Sanofi, BMS; presentations for Nanobiotix, BMS; educational grant from Medscape/Bayer.D Juric: Consulting/advisory role with Eisai, EMD Serono, Genentech, Ipsen, Novartis; research funding from Eisai, EMD Serono, Genentech, Novartis, Placon, Takeda.GI Shapiro: Advisory role with Lilly, Pfizer, Merck/EMD Serono, G1 Therapeutics, Roche; research funding from Lilly, Pfizer, and Merck/EMD Serono.C Vanderwal, B Hu, M Gifford, D Barch, L Roberts-Rapp, PJ Ansell, H Xiong, C Ocampo: Employees of AbbVie and may own stock.AW Tolcher: Employed by START; consulting/advisory role for Bayer Schering Pharma, Blend Therapeutics, Celator, Janssen, Merus, Nanobiotix, Pierre Fabre, Symphogen, Heron, Asana BioSciences, Akebia Therapeutics, Genmab, Johnson & Johnson, Endocyte, Upsher-Smith, Ascentage, Bicycle Therapeutics, Boehringer Ingelheim, Ignyta, MEDIAN Technologies, OncoMed, Zymeworks, Elekta, Rigontec, New B Innovation (all to institution); leadership role for Symphogen; research funding from AbbVie, ArQule, Asana BioSciences, Astex Pharmaceuticals, Cerulean Pharma, Dicerna, Endocyte, Gilead Sciences, Infinity Pharmaceuticals, MacroGenics, Pfizer, TaiRx, Inc., Bayer, Otsuka, Plexxikon (all to institution).AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: ExternalRef removed.
: All patients provided written informed consent, and local ethics committee approval was obtained. This study was conducted in accordance with good clinical practice guidelines and the 1964 Helsinki declaration and its later amendments or comparable ethical standards.This article does not contain any studies with animals performed by any of the authors.
: Informed consent was obtained from all individual participants included in the study.